ConstipationPhase 1NCT01674192
Prucalopride Subjects With Renal Impairment
A Phase 1 study testing prucalopride in people with Constipation, run by Movetis.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics of a single 2 mg oral dose of prucalopride in subjects with various degrees of renal impairment compared with normal renal function and to monitor the safety profile of prucalopride in subjects with renal impairment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Constipation
- What is being tested?
- prucalopride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Jul 1997to Aug 1999
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Child, Adult, Older adult
Who may be able to join
- All subjects had to meet the following inclusion criteria:
- Between the ages of 18 and 75 years, inclusive;
- Males or females. Females were to be of non-childbearing potential.
- Normal subjects had to meet the following additional inclusion criteria:
- Demographically comparable to the subjects with renal impairment, within 30% of mean weight and height and 10% of the mean age;
- Physical examination, clinical laboratory results, and 12-lead ECG within normal limits at screening;
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- No intake of medication, including over-the-counter medication, during a pre-trial 7-day drug-free washout period;
- Subjects with renal impairment had to meet the following additional inclusion criteria:
- Stable severity of renal disease;
- Concomitant medications to treat underlying disease states or medical conditions related to renal insufficiency were allowed;
- Stable dose of medication and/or treatment regimen from 2 months prior to and during the trial;
- Subjects with stable cardiovascular disease could be enrolled, provided that the investigator felt their condition would not interfere with the results of the trial.
Who cannot join
- All subjects who met any of the following criteria were excluded from the trial:
- History of hypersensitivity to prucalopride or inactive ingredients in the prucalopride capsule or to related prokinetic compounds;
- Use of any other investigational drug within 30 days prior to signing the consent or intention to take any investigational drug during the trial;
- History of significant blood loss, or blood plasma donation (500mL) within the last 30 days;
- Pregnancy or breast feeding;
- Gastrointestinal (GI) surgery within 3 months, or history of major GI surgery with potential compromise of drug absorption or metabolism;
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- Normal subjects who met any of the following criteria were excluded from the trial:
- Any abnormal medical history, physical examination, ECG, or laboratory results;
- Use of medications 7 days prior to and during the trial.
- Subjects with renal impairment who met any of the following criteria were excluded from the trial.
- Any abnormality in medical history, physical examination, ECG, or laboratory results that, in the opinion of the investigator, might affect the safety of the subject;
- History of uric acid stone disease, uricosuria, or gout, or current hyperuricemia;
- Renal transplants, lupus erythematosus, or renal carcinoma.
About this study
Official title: Single Dose Pharmacokinetic Trial of Oral Prucalopride (R093877) in Subjects With Mild, Moderate and Severe Renal Impairment
The purpose of this study is to evaluate the pharmacokinetics of a single 2 mg oral dose of prucalopride in subjects with various degrees of renal impairment compared with normal renal function and to monitor the safety profile of prucalopride in subjects with renal impairment.
Hypothesis:
Prucalopride might accumulate and exhibit a different pharmacokinetic profile in renally impaired subjects compared with the normal population.
Read the detailed description
This is a single-centre, open label, single-dose, pharmacokinetic trial with prucalopride in subjects with varying degrees of renal impairment. Subjects were classified into one of four renal function groups, as defined by a 24-hour creatinine clearance determination (CRCL) obtained within 2 weeks before trial entry. Each subject was administered a single 2mg oral dose of prucalopride. Plasma samples and complete urine collections were obtained from 0 through 120 h (6 days) after dosing to characterize the pharmacokinetics of prucalopride.
- Conditions
- Constipation
- Being tested
- prucalopride
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prucaloprideDrug
single dose of 2 mg prucalopride
| Study group | Role | What they receive |
|---|---|---|
| prucalopride | Experimental | single dose of 2 mg prucalopride Receives: Drug: prucalopride |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the Pharmacokinetic profile of prucalopride in subjects with various degrees of renal impairement
Secondary outcomes (1)
Secondary efficacy variables: to evaluate the safety and tolerability of prucalopride in subjects with various degrees of renal impairement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startJul 1997
- Primary completionAug 1999
- Study completionAug 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Movetis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- W. Smith, M.D., Principal investigator, New Orleans Center for Clinical Research, 2820 Canal Street, New Orleans, LA 70119
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01674192
- Sponsor's protocol ID
- PRU-USA-6
- Status last verified
- Jun 2012
- First submitted
- 24 Aug 2012
- Last updated
- 28 Aug 2012
- Results posted
- No
Publications
Smith WB, Mannaert E, Verhaeghe T, Kerstens R, Vandeplassche L, Van de Velde V. Effect of renal impairment on the pharmacokinetics of prucalopride: a single- dose open-label Phase I study. Drug Des Devel Ther. 2012;6:407-15. doi: 10.2147/DDDT.S36142. Epub 2012 Dec 18.
PubMed 23269861
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Pharmacokinetic Trial of Oral Prucalopride (R093877) in Subjects With Mild, Moderate and Severe Renal Impairment
- ClinicalTrials.gov ID
- NCT01674192
- Acronym / sponsor ID
- PRU-USA-6
- Conditions
- Constipation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- MovetisIndustry (pharma, biotech, devices)
- Study start
- Jul 1997
- Primary completion
- Aug 1999 (actual)
- Study completion
- Aug 1999 (actual)
- First posted
- 28 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the pharmacokinetics of a single 2 mg oral dose of prucalopride in subjects with various degrees of renal impairment compared with normal renal function and to monitor the safety profile of prucalopride in subjects with renal impairment.
Hypothesis:
Prucalopride might accumulate and exhibit a different pharmacokinetic profile in renally impaired subjects compared with the normal population.
Detailed description
This is a single-centre, open label, single-dose, pharmacokinetic trial with prucalopride in subjects with varying degrees of renal impairment. Subjects were classified into one of four renal function groups, as defined by a 24-hour creatinine clearance determination (CRCL) obtained within 2 weeks before trial entry. Each subject was administered a single 2mg oral dose of prucalopride. Plasma samples and complete urine collections were obtained from 0 through 120 h (6 days) after dosing to characterize the pharmacokinetics of prucalopride.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| prucalopride | Experimental | Drug: prucalopridesingle dose of 2 mg prucalopride |
Who may qualify
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Between the ages of 18 and 75 years, inclusive;
- Males or females. Females were to be of non-childbearing potential.
- Demographically comparable to the subjects with renal impairment, within 30% of mean weight and height and 10% of the mean age;
- Physical examination, clinical laboratory results, and 12-lead ECG within normal limits at screening;
- No intake of medication, including over-the-counter medication, during a pre-trial 7-day drug-free washout period;
Key exclusion criteria (13 listed)
- History of hypersensitivity to prucalopride or inactive ingredients in the prucalopride capsule or to related prokinetic compounds;
- Use of any other investigational drug within 30 days prior to signing the consent or intention to take any investigational drug during the trial;
- History of significant blood loss, or blood plasma donation (500mL) within the last 30 days;
- Pregnancy or breast feeding;
- Gastrointestinal (GI) surgery within 3 months, or history of major GI surgery with potential compromise of drug absorption or metabolism;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prucalopridesingle dose of 2 mg prucalopride | Drug | prucalopride |
Primary outcome
To characterize the Pharmacokinetic profile of prucalopride in subjects with various degrees of renal impairement
1 secondary outcome
Secondary efficacy variables: to evaluate the safety and tolerability of prucalopride in subjects with various degrees of renal impairement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2012.
- Derived from this study: PubMed 23269861Smith WB, Mannaert E, Verhaeghe T, Kerstens R, Vandeplassche L, Van de Velde V. Effect of renal impairment on the pharmacokinetics of prucalopride: a single- dose open-label Phase I study. Drug Des Devel Ther. 2012;6:407-15. doi: 10.2147/DDDT.S36142. Epub 2012 Dec 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
W. Smith, M.D. principal investigator
New Orleans Center for Clinical Research, 2820 Canal Street, New Orleans, LA 70119
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing prucalopride in people with Constipation, run by Movetis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To characterize the Pharmacokinetic profile of prucalopride in subjects with various degrees of renal impairement. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01674192, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2012.